Administering Drugs With Nanoneedles

By

Emily Veach

Updated Sept. 21, 2010 12:01 a.m. ET

A small patch full of tiny needles could help patients, doctors and hospitals overcome some of their most dangerous problems. Suzhou Natong Bionanotechnology Co. of China has developed a pain-free drug-delivery device.

In addition, the company's Functional MicroArray needles eliminate the danger to doctors and nurses of accidental sticking, reduce the needle-disposal problem faced by hospitals and allow greater product lifetime for pharmaceutical companies. In this way the technology cuts across several industries.

"Our nanoneedles are very, very small, smaller than a human hair," said Bai Xu, president, chief executive and founder. They deliver drugs by perforating the skin barrier, but they are so short they don't hit nerve endings or blood vessels. The MicroArray patch, a finalist in this year's Asian Innovation Awards, is reusable and holds a 5mm-square chip that contains about 400 tiny needles. Square patches range in size from 1 to 1.5 centimeters long.

In addition to applications in diabetes, skin disease and pain relief, the company launched an acne treatment called LiteClear in China in March. The root of acne problems is clogged pores. The company's nanoneedles manage to open clogged pores to let oil out and let medicine in, Mr. Xu said. The cosmeceutical industry has grown to about $2.5 billion a year, he said. Meanwhile, the size of the pain-management industry is about $5 billion a year, and the insulin industry is about $10 billion a year.

One of the greatest challenges to developing the product, Mr. Xu said, has been gaining regulatory approval. The MicroArray is a multidisciplinary technology, and regulators weren't quite sure whether it was a device or a drug. Mr. Xu's job is helping to bridge communication barriers among several industries to make sure they understand each other.

There is a lot of misconception about the technology. "Very few people can define it," Mr. Xu said. "I believe we are in the hardest area in nanotechnology, called multiskilled integration. We cannot see it, we cannot feel it unless we miniaturize our human being." He said he has to help people outside the field understand the technology.

Natong has received patents in the U.S. and China. One of its great successes, Mr. Xu said, has been shortening the product's time-to-market. Natong has a low-cost manufacturing facility in China and plans to increase production as more products are approved.

The company has performed human testing for its products, while animal testing was used only on the pharmaceutical product, not on the cosmetic product. Mr. Xu said the tests were conducted under supervision from a Harvard consultant who adhered to U.S. Food and Drug Administration guidelines. The company's scientists found their device is best suited for drugs that need subcutaneous delivery. Drugs administered through IVs are not ideal because nanoneedles do not reach the blood vessels. About 95% of current biomedical drugs are currently delivered through needle injections. "We don't pretend we can replace all needle injections," he said, but they could replace as much as 70% of them.

Nanofabrication technology, Mr. Xu explained, has its roots in semiconductors. It is "thin technology." Research and development for the product started three years ago. About five years before that scientists were working with the Chinese government on early-stage research. The government has become very aggressive in funding new technology, he said. The company was founded in 2007 with $1.5 million from the local Chinese government. Years earlier, he attempted to raise funds in Silicon Valley while he was based in upstate New York, where he lives now, but was unsuccessful. "They joked, 'you have more cows than people there,' " he recalled during a recent phone interview from Suzhou, China, where the factory is located.

ENLARGE

Suzhou Natong Bionanotechnology's technicians
Natong

Most recently, the company finished first in a regional DemoChina competition. Soon after, Mr. Xu said, a Softbank partner heard about the product and "in less than three months, they were ready to give us a term sheet" detailing funding that came in at several million U.S. dollars, enabling the launch of LiteClear acne treatment. Natong has been developing relationships with pharmaceutical companies and distributors that have already established channels to consumers.

Natong has competitors such as drug majors Johnson & Johnson and 3M Co., and they like it that way. The difference, Mr. Xu said, is that its competitors use a different sort of technology with different materials and needle lengths. Natong's needles are about one-tenth of the length of Johnson & Johnson's, he said.

"As an engineer I think it's a very rewarding experience to see one's product used broadly, and it can help people reduce their pain," he said. "That's more important than how many millions we might make."

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